Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) (MELATOZINC)

August 8, 2018 updated by: Laboratorios Viñas, S.A.

An Unicentric, Double-blind, Placebo Controlled, Phase IV Clinical Trial of Oral Melatonin Plus Zinc to Evaluate Relieving Self-reported Fatigue in CFS/ME

The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a complex medical condition, characterized by severe disabling fatigue with no known cause, no established diagnostic tests, and no universally effective treatment. No studies have evaluated symptomatic treatment using oral melatonin plus zinc supplementation in CFS/ME. The primary endpoint was to assess the effect of melatonin plus zinc supplementation on self-reported fatigue. Secondary measures included self-reported outcomes of sleep problems, anxiety/depression, dysautonomia, QoL and side-effects during treatment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Vall D'Hebron University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
  • Patient who provided signed informed consent.

Exclusion Criteria:

  • Patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion.
  • Any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment.
  • Subjects that do not provide signed informed consent.
  • Patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem.
  • Patients receiving oral anticoagulants.
  • Pregnancy or lactation
  • Patients with hypersensitivity to melatonin and/or zinc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin plus Zinc
Dietary supplement: melatonin plus zinc
Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
Other Names:
  • MelatoZinc
Placebo Comparator: Placebo
Isomaltose
Other: Placebo
Isomaltose o.d. 1 hour before going to bed during 16 weeks
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate relieving self-reported fatigue using the Fatigue Impact Scale 40-items (FIS 40) questionnaire after oral melatonin plus zinc administration
Time Frame: within the first 16 weeks (plus 4 weeks with no treatment)
within the first 16 weeks (plus 4 weeks with no treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects during treatment.
Time Frame: within the first 16 weeks (plus 4 weeks with no treatment)
within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported sleep quality through the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Time Frame: within the first 16 weeks (plus 4 weeks with no treatment)
within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported anxiety/depression through the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Time Frame: within the first 16 weeks (plus 4 weeks with no treatment)
within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported dysautonomia using the Composite Autonomic Symptom Score 31-items (COMPASS 31) questionnaire.
Time Frame: within the first 16 weeks (plus 4 weeks with no treatment)
within the first 16 weeks (plus 4 weeks with no treatment)
Self-reported QoL through the Short Form Health Survey 36-items (SF-36) questionnaire.
Time Frame: within the first 16 weeks (plus 4 weeks with no treatment)
within the first 16 weeks (plus 4 weeks with no treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Viñas, S.A.

Collaborators

Hospital Vall d'Hebron
Laboratorio Echevarne

Investigators

  • Principal Investigator: José Alegre, MD; PhD, Vall D'Hebron University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC/LV/MEL-ZN/SFC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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